北美单轨支架取栓器急性卒中注册研究：上市后血管再通及临床结局结果
North American Solitaire Stent Retriever Acute Stroke registry: post-marketing revascularization and clinical outcome results.
作者信息
Zaidat Osama O, Castonguay Alicia C, Gupta Rishi, Sun Chung-Huan J, Martin Coleman, Holloway William E, Mueller-Kronast Nils, English Joey D, Linfante Italo, Dabus Guilherme, Malisch Tim W, Marden Franklin A, Bozorgchami Hormozd, Xavier Andrew, Rai Ansaar T, Froehler Michael T, Badruddin Aamir, Nguyen Thanh N, Taqi M Asif, Abraham Michael G, Janardhan Vallabh, Shaltoni Hashem, Novakovic Roberta, Yoo Albert J, Abou-Chebl Alex, Chen Peng R, Britz Gavin W, Kaushal Ritesh, Nanda Ashish, Issa Mohammad A, Nogueira Raul G
机构信息
Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA Department of Neurosurgery, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA Department of Radiology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA.
Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA.
出版信息
J Neurointerv Surg. 2014 Oct;6(8):584-8. doi: 10.1136/neurintsurg-2013-010895. Epub 2013 Sep 23.
BACKGROUND
Limited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials.
METHODS
The investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage.
RESULTS
354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3% (315/354) and TICI ≥2a rate of 87.5% (310/354) compared with the operator reported TIMI ≥2 rate of 83% in SWIFT and TICI ≥2a rate of 85% in TREVO 2.
CLINICAL OUTCOME
42% (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37% (SWIFT) and 40% (TREVO 2). 90 day mortality was 30.2% (95/315) versus 17.2% (SWIFT) and 29% (TREVO 2).
CONCLUSIONS
The NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.
背景
关于Solitaire FR装置在临床实践中的使用，上市后数据有限。北美Solitaire支架取栓器急性卒中（NASA）注册研究旨在评估Solitaire FR装置在现实世界中的性能，并与SWIFT（血栓切除术意向性使用Solitaire）和TREVO 2（急性缺血性卒中大血管闭塞血栓切除术再血管化中Trevo与Merci取栓器对比）试验的结果进行对比。
方法
研究者发起的NASA注册研究招募了北美各研究点，以提交2012年3月至2013年2月期间接受Solitaire FR治疗的连续性急性缺血性卒中（AIS）患者的回顾性血管造影和临床结局数据。主要结局为心肌梗死溶栓（TIMI）评分≥2或脑梗死治疗（TICI）评分≥2a。次要结局为90天改良Rankin量表（mRS）评分、死亡率和症状性颅内出血。
结果
24个中心的354例患者使用Solitaire FR装置治疗AIS。从发病到腹股沟穿刺的平均时间为363.4±239分钟，平均透视时间为32.9±25.7分钟，平均手术时间为100.9±57.8分钟。再通结局：TIMI≥2率为83.3%（315/354），TICI≥2a率为87.5%（310/354），而术者报告的SWIFT试验中TIMI≥2率为83%，TREVO 2试验中TICI≥2a率为85%。
临床结局
NASA研究中的患者42%（132/315）在90天时mRS≤2，而SWIFT试验中为37%，TREVO 2试验中为40%。90天死亡率为30.2%（95/315），而SWIFT试验中为17.2%，TREVO 2试验中为29%。
结论
NASA注册研究表明，Solitaire FR装置在临床实践中的性能与SWIFT和TREVO 2试验结果相当。
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